Medical device and method of delivering the medical device

ABSTRACT

The invention discloses an implant. The implant may include a first flap and a second flap. The first flap may further include a first portion, a second portion and a transition region. The first portion may be configured to be attached proximate a sacrum. The second portion may be configured to be attached to an anterior vaginal wall. The transition region lies between the first portion and the second portion. The second flap may be fabricated such that a portion of the second flap is configured to be attached to a posterior vaginal wall. The implant may be configured such that a value corresponding to a biomechanical parameter defining a biomechanical attribute of the portion of the first flap attaching to the anterior wall is different from a value of the biomechanical parameter defining the biomechanical attribute of the portion of the second flap attaching to the posterior wall.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Nonprovisional of, and claims priority to, U.S.Patent Application No. 61/779,523, filed on Mar. 13, 2013, entitled“MEDICAL DEVICE AND METHOD OF DELIVERING THE MEDICAL DEVICE”, and U.S.Patent Application No. 61/891,186, filed on Oct. 15, 2013, entitled“MEDICAL DEVICE AND METHOD OF DELIVERING THE MEDICAL DEVICE”, thedisclosures of which are incorporated by reference herein in theirentirety.

BACKGROUND

Field

The present invention generally relates to medical devices andprocedures, and particularly, devices configured to be delivered andplaced in a patient's body for the treatment of pelvic floor disorderand methods thereof.

Description of the Related Art

Pelvic organ prolapse is an abnormal descent or herniation of the pelvicorgans. A prolapse may occur when muscles and tissues in the pelvicregion become weak and can no longer hold the pelvic organs in placecorrectly.

Treatment for symptoms of the pelvic organ prolapse can include changesin diet, weight control, and lifestyle. Treatment may also includesurgery, medication, and use of grafts to support the pelvic organs.

Sacrocolpopexy is one such surgical technique that may be used to repairpelvic organ prolapse. This can be performed using an open abdominaltechnique or with the use of minimally invasive surgery, such aslaparoscopy or robotic-assisted surgery. The technique includessuspension of the apical portion of vagina (or sometimes the vaginalcuff after hysterectomy) using an implant such that the technique triesto recreate the natural anatomic support.

In some cases, a Y-shaped implant may be used to treat vaginal vaultprolapse during the sacrocolpopexy procedure. The Y-shaped implant aidsvaginal cuff suspension to the sacrum and provides long-term support.The procedure can be minimally invasive (laparoscopic sacral colpopexy)or traditional (open sacral colpopexy). Also, in some cases, differentanatomical locations inside a patient's body for example, vagina,uterus, and sacrum may be involved in repair of the pelvic organprolapse. For example, at least a portion of the implant may be attachedto an anterior vaginal wall, and a posterior vaginal wall in some cases.These anatomical locations have different biological attributes andbehave differently. Therefore, the implant may not conform to thevarying behavior of the different anatomical locations where the implantportions are attached. One reason for matching biomechanical propertiesof tissue with an implant is to promote tissue viability. In some cases,when an implant supports a higher force than the tissue attached to it,the tissue atrophies. In some cases this may lead to breakdown in thetissue structure as well as pain for patient.

Thus, there is a need for an implant that has different properties atdifferent locations along the implant. Additionally, in light of theabove, there is a need for an improved implant that can be fabricated toconform to varying behavior of different anatomical locations inside apatient's body.

SUMMARY

In an embodiment, the invention discloses an implant. The implant mayinclude a first flap and a second flap. The first flap may furtherinclude a first portion, a second portion and a transition region. Thefirst portion may be configured to be attached proximate a sacrum. Thesecond portion may be configured to be attached to an anterior vaginalwall. The transition region lies between the first portion and thesecond portion. The second flap may be fabricated such that a portion ofthe second flap is configured to be attached to a posterior vaginalwall. The implant may be configured such that a value corresponding to abiomechanical parameter defining a biomechanical attribute of theportion of the first flap attaching to the anterior wall is differentfrom a value of the biomechanical parameter defining the biomechanicalattribute of the portion of the second flap attaching to the posteriorwall.

In an embodiment, the invention discloses a tubular implant. The tubularimplant includes a first portion, a second portion, and a transitionregion. The first portion of the tubular implant can be configured to beattached proximate a sacrum. The transition region can extend from thefirst portion. The second portion can extend from the transition regionmonolithically. The second portion includes a first section and a secondsection and two slits provided laterally in the second portionconfiguring the first section as apart from the second section at aproximal end. The tubular implant further includes a lumen definedwithin the first and second portions of the tubular implant. The tubularimplant can be configured such that the first section is configured tobe attached to an anterior vaginal wall, and the second section isconfigured to be attached to a posterior vaginal wall.

In an embodiment, the invention discloses a method for placing animplant in a body of a patient. The method includes inserting theimplant inside the body. The method further includes attaching a portionof the implant to an anterior vaginal wall, wherein the portionattaching to the anterior vaginal wall defines a first value of abiomechanical parameter defining a biomechanical attribute. The methodfurther includes attaching a portion of the implant to a posteriorvaginal wall. The portion attaching to the posterior vaginal walldefines a second value of the biomechanical parameter such that thesecond value corresponding to the portion attaching to the posteriorwall is different from the first value corresponding to the portionattaching to the anterior wall.

BRIEF DESCRIPTION OF THE FIGURES

The invention and the following detailed description of certainembodiments, thereof, may be understood with reference to the followingfigures:

FIG. 1 is a schematic diagram of a medical assembly for treatment of apelvic floor disorder, in accordance with an embodiment of theinvention.

FIG. 2 is a top view of a portion of a medical implant for placing overan anterior vaginal wall and a sacrum inside a patient's body.

FIG. 3 is a top view of a portion of a medical implant for placing overa posterior wall of a vagina and a sacrum inside a patient's body.

FIG. 4 is a perspective view of a medical implant including multipleflaps for placing over an anterior vaginal wall, a posterior vaginalwall, and a sacrum, in an embodiment of the present invention.

FIG. 5A is a perspective view of a tubular shaped medical implantincluding portions to be attached to a sacrum or proximate the sacrum,an anterior vaginal wall and a posterior vaginal wall in an embodimentof the invention.

FIG. 5B is a perspective view of a portion of the tubular shaped medicalimplant with a pore construct in a closed position, in accordance withan embodiment of the invention.

FIG. 5C is a perspective view of the tubular shaped medical implant withthe pore construct in a closed position, in accordance with anembodiment of the invention.

FIG. 6A is a graphical representation of relationship between stressapplied on a vaginal tissue and resulting elongation in a vaginal tissuedue to the applied stress.

FIG. 6B is a graphical representation of a comparison of an exemplaryattribute, elongation, of the vaginal tissue in a transverse directionand a longitudinal direction.

FIG. 7 is a perspective view of the medical implant of FIG. 2 and FIG. 3placed inside a patient's body.

FIG. 8 is a flowchart illustrating a method for treatment of a pelvicfloor disorder, in accordance with an embodiment of the presentinvention.

DETAILED DESCRIPTION

Detailed embodiments of the present invention are disclosed herein;however, it is to be understood that the disclosed embodiments aremerely exemplary of the invention, which may be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure. Further, the terms and phrases usedherein are not intended to be limiting, but to provide an understandabledescription of the invention.

The terms “a” or “an,” as used herein, are defined as one or more thanone. The term “another,” as used herein, is defined as at least a secondor more. The terms “including” and/or “having”, as used herein, aredefined as comprising (i.e., open transition).

In general, the invention is directed to systems, methods, and devicesfor treating vaginal prolapse. However, the invention may be equallyemployed for other treatment purposes such as pelvic organ prolapse orother pelvic disorders such as incontinence. As described below invarious illustrative embodiments, the invention provides systems,methods, and devices employing a medical device configured to deliver orplace an implant within a patient's body to support pelvic organs anddeliver a fluid such as a medication inside the body such as to theimplant site for the treatment of pelvic organ prolapse or other pelvicdisorders.

The term patient may be used hereafter for a person who benefits fromthe medical device or the methods disclosed in the present invention.For example, the patient may be a person whose body is operated with theuse of the medical device disclosed by the present invention in asurgical treatment. For example, in some embodiments, the patient may bea human female, human male or any other mammal.

The terms proximal and distal described in relation to various devices,apparatuses, and components as discussed in the subsequent text of thepresent invention are referred to with a point of reference. The pointof reference, as used in this description, is a perspective of anoperator. The operator may be a surgeon, a physician, a nurse, a doctor,a technician, and the like who may perform the procedure of delivery andplacement of the bodily implants into the patient's body as described inthe present invention. The term proximal refers to an area that isclosest to the operator. The term distal refers to an area that isfarthest from the operator.

FIG. 1 is a schematic diagram of an implant 100. The implant 100 caninclude a first flap 102. The first flap 102 can include a first portion104, a second portion 106 and a transition region 108. In an embodiment,the implant 100 can be used for the treatment of a pelvic floordisorder. In some embodiments, the implant 100 can be used to suspendvarious bodily locations in a body of a patient. For example, in someembodiments, the implant 100 can be used to suspend a pelvic organ of apatient's body. In some embodiments, the implant 100 can be a part of aretropubic incontinence sling. In some embodiments, the implant 100 canbe configured to be delivered by way of a transvaginal approach or atransobturator approach or vaginal pre-pubic approach or a laparoscopicapproach or can be delivered through other approaches and positioned atvarious locations within a patient's body.

The first portion 104 defines a first side 110, a second side 112, aproximal portion 114 and a distal portion 116. The proximal portion 114can be attached to or extend from the transition region 108 of the firstflap 102. The distal portion 116 can be configured to be attached to afirst bodily tissue. In some embodiments, the first bodily tissue can bea sacrum or tissue proximate a sacrum of a patient. In some embodiments,the first bodily tissue can be any one of lumbar vertebra, tail bone,and ileum portion of hip bone inside the patient's body. In someembodiments, the first bodily tissue can be any other location insidethe patient's body.

The first portion 104 defines a length L1 along the first side 110extending from the proximal portion 114 to the distal portion 116. Thefirst portion 104 defines a length L2 along the second side 112extending from the proximal portion 114 to the distal portion 116. Insome embodiments, the length L1 can be equal to the length L2. In someembodiments, the length L1 can be different from the length L2. Thefirst portion 104 defines a width W1 extending between the first side110 and the second side 112. In some embodiments, the width W1 canremain constant from the proximal portion 114 to the distal portion 116.In some embodiments, the width W1 can differ from the proximal portion114 to the distal portion 116.

The first bodily tissue exhibits a definite biomechanical behavior in adefined set of physical conditions. The first portion 104 can beconfigured to define a set of biomechanical attributes or biomechanicalproperties so as to emulate the biomechanical behavior of the firstbodily tissue, where at least a portion of the first portion 104 isrequired to be attached, in the defined set of physical conditions. Thebiomechanical attributes for the first bodily tissue can be defined by afirst set of values of respective biomechanical parameters associatedwith each of the biomechanical attributes. For example, in someembodiments, the biomechanical attribute can be elasticity and acorresponding biomechanical parameter can be modulus of elasticity whichcan be defined by a numerical value. While the use of a modulus (such asa modulus of elasticity) is used to measure a biomechanical parameter,it should be understood that the biomechanical parameter of the bodilytissue may also be directly measured. For example, in some embodiments,the elasticity of the bodily tissue maybe measured (without using amodulus). In some embodiments, the biomechanical attribute can bestiffness. In some embodiments, the biomechanical attribute can bestrength. In some embodiments, the biomechanical attribute can beresistance to creep. In various embodiments, the biomechanicalattributes of the first portion 104 can be defined for example bydefining one or more of shape, size, fabrication method, structure,profile, knit structure, pore size, material of fabrication, fiberorientation, and the like. In some embodiments, for example, thecongruence between the biomechanical behavior of the first bodily tissueand the first portion 104 can be achieved by varying the shape of thefirst portion 104. For example, the first portion 104 can have a square,rectangular, triangular or any other shape, which can facilitate thefirst portion 104 in closely equating the biomechanical behavior of thefirst bodily tissue. Adding apertures or reinforcements at specificsites along the implant can affect the biomechanical properties.Utilizing materials with properties that change over time, such asbiodegradable materials, can adjust specific biomechanical propertiesover time. Coatings on specific portions of the implant may be used toinfluence the biomechanical properties, for example but reducing theelasticity of the coated portion.

In some embodiments, the biomechanical attributes of the first portion104 can be defined by a first type of knit structure (not shown here andexplained later). In some embodiments, the first type of knit structurecan be defined by first type of knitting pattern (not shown here andexplained later). In some embodiments, the first type of knit structurecan be defined by a first type of pore construct. In some embodiments,the first type of knit structure can be defined by weaving the knit witha required and defined tension. For example, the first knitting patterncan be woven tightly or loosely to define required type of knittingpattern. In some embodiments, the first knitting pattern characterizedby biomechanical properties of high elastic modulus and stiffness canfacilitate holding onto the first bodily tissue such as a sacrum in thecorrect anatomical location. The different ways of achieving thedesirable biomechanical attributes for the first portion 104 of thefirst flap 102 can be used in isolation or in combination. It must beappreciated that though the above ways of defining the requiredbiomechanical attributes are used for mesh-based implants 100 includinga knit pattern, the implant 100 can be fabricated as a planar structure.In such embodiments, the biomechanical attributes of the first portion104 of the first flap 102 of the implant 100 can be defined for exampleby the material used in fabrication of the first portion 104, shape andsize of the portion, and the like without limitations. For example, arigid medical grade polymer can be used for fabricating the firstportion 104 thereby defining the biomechanical attribute of rigidity forthe first portion 104 to a desired value.

The second portion 106 defines a first side 118, and a second side 120,a proximal portion 122 and a distal portion 124. The distal portion 124can be attached to or extend from the transition region 108 of the firstflap 102. The proximal portion 122 can be configured to be attached to asecond bodily tissue. In some embodiments, the second bodily tissue canbe an anterior vaginal wall inside a patient's body. In someembodiments, the second bodily tissue can be at least one of a posteriorvaginal wall, a uterus, and a vaginal apex. In some embodiments, thesecond bodily tissue can be any other location inside the patient'sbody.

The second portion 106 defines a length L3 along the first side 118extending from the proximal portion 122 to the distal portion 124. Thesecond portion 106 defines a length L4 along the second side 120extending from the proximal portion 122 to the distal portion 124. Insome embodiments, the length L3 can be equal to the length L4. In someembodiments, the length L3 can be different from the length L4. Thesecond portion 106 defines a width W2 extending between the first side118 and the second side 120. In some embodiments, the width W2 canremain constant from the proximal portion 122 to the distal portion 124.In some embodiments, the width W2 can differ from the proximal portion122 to the distal portion 124. In some embodiments, the second portion106 is fabricated such that the width W2 of the second portion 106 isgreater than the width W1 of the first portion 104. In some embodiments,the second portion 106 can define a trapezoidal shape such that thewidth W2 at the proximal portion 122 is substantially greater than thewidth W2 at the distal portion 124. In some embodiments, the secondportion 106 can have a polygonal shape. In some embodiments, the secondportion 106 can have a square, rectangular, triangular or any othershape.

The second bodily tissue exhibits a definite biomechanical behavior in adefined set of physical conditions. The behavior exhibited by the secondbodily tissue can be different than the behavior exhibited by the firstbodily tissue. The second portion 106 can be configured to define thebiomechanical attributes or biomechanical properties so as to emulatethe biomechanical behavior of the second bodily tissue in the definedset of physical conditions. The biomechanical attributes can be definedby a second set of values of respective biomechanical parametersassociated with each of the biomechanical attributes. Consequently, thesecond portion 106 may be defined to exhibit values of the biomechanicalattributes, different than the values of the biomechanical attributes ofthe first portion 104, in accordance with the second bodily tissue whereat least a portion of the second portion 106 of the first flap 102 maybe attached. It must be appreciated that in some embodiments, only oneor more but not all of the first set of values biomechanical attributesand the second set of values differ in terms of their values ofparameters defining the respective attributes. For example, the modulusof elasticity may be same for the first portion 104 and the secondportion 106 but any other parameter for other attribute such asresistance to creep may be different. In some other embodiments, all theattributes of the first portion 104 and the second portion 106 maydiffer in terms of their numerical values of parameters defining therespective attributes.

In some embodiments, the second set of values associated with thebiomechanical attributes can be different along different directions forthe same fixed set of physical conditions even for the same attribute.For example, in some embodiments, a value of a parameter P defining anattribute T along a first direction A1 can be different from a value ofthe parameter P defining the attribute T along a second direction A2. Insome embodiments, the first direction A1 can be a longitudinal directionand the second direction A2 can be a transverse direction.

It must be appreciated that the biomechanical behavior of the bodilytissues and the biomechanical attributes of the various portions of theimplant 100 may change owing to change in physical conditions.Therefore, for the purpose of comparing the various biomechanicalbehaviors and the biomechanical attributes, a reasonably sufficientamount of similarity in physical conditions may be assumed to an extentthat a change in the conditions creates an ignorable influence. However,in other embodiments, the physical conditions may vary and measurementof the biomechanical behavior and the attributes may accordingly becalibrated so as to compare the various values associated with thevarious attributes in light of the required characteristics at therequired locations. For example, the stiffness of the first portion 104and the second portion 106 may be different initially during fabricationbut since the physical conditions at the respective bodily tissues maybe different, therefore the initial values of the stiffness may notremain same after placement. This change due to variation in thephysical conditions may be considered while defining the attributes ofthe respective portions of the implant 100 so as to achieve the desiredset of attributes with the desired set of values.

In some embodiments, the biomechanical attributes can include elasticityand a corresponding biomechanical parameter can be modulus ofelasticity. In some embodiments, the biomechanical attribute can beviscoelasticity. In some embodiments, the biomechanical attribute can beviscohyperelasticity. In some embodiments, the biomechanical attributecan be anisotrophicity. In various embodiments, the biomechanicalattributes of the second portion 106 can be defined by defining one ormore of shape, size, fabrication method or structure, profile, knitstructure, pore size, material of fabrication, and the like. In someembodiments, for example, the congruence between the biomechanicalbehavior of the second bodily tissue and the second portion 106 can beachieved by varying the shape of the second portion 106. For example,the trapezoidal shape of the second portion 106 can conform to shape ofthe second bodily tissue such as the anterior vaginal wall inside apatient's body.

In some embodiments, the biomechanical attributes of the second portion106 can be defined a second type of knit structure (not shown here andexplained later). In some embodiments, the second type of knit structurecan be defined by second type of knitting pattern (not shown here andexplained later). In some embodiments, the second type of knit structurecan be defined by weaving the knit (or knitting) with a required anddefined tension. For example, the anterior vaginal wall showsbiomechanical behavior of anisotrophicity, with bias toward moreelongation along a transverse direction, therefore, the second type ofknitting pattern can be selected so as to be more elastic along alongitudinal direction as compared to the transverse direction.

In some embodiments, the second type of knit structure can be defined bya second type of pore construct. In some embodiments, the second type ofpore construct is different from the first type of pore construct. Insome embodiments, the second pore construct includes a larger pore sizeas compared to a pore size of the first pore construct. In someembodiments, the difference in pore constructs of the first and secondportions 104 and 106 can be achieved by weaving a mesh with differentpore sizes. In some embodiments, the difference in pore constructs forthe first and second portions 104 and 106 can be achieved by extrudingor knitting a single pore size mesh and heat setting the pores to set adifferent pore size for the first and second portions 104 and 106 asillustrated and described by later figures. The second pore constructcan define the second set of values of the biomechanical attributes ofthe second portion 106. In an embodiment, the second pore construct candefine larger pore sizes as compared to the remaining portion of theimplant 100. In some embodiments, the second pore construct can befabricated to exhibit biomechanical attributes of high flexibility andelongation to a particular strain level and high stiffness after theparticular stain level is reached. Such a strain behavior may closelyemulate the biomechanical behavior of the vaginal wall for example theanterior vaginal wall. Therefore, the second pore structure defines thebiomechanical attributes so as to conform to the biomechanical behaviorof the second bodily tissue that is the vaginal wall.

In some embodiments, the values associated with the biomechanicalattributes can be defined by a material used for fabricating the secondportion 106. For example, a viscoelastic medical grade polymer can beused for fabricating the second portion 106 thereby defining a value forthe biomechanical attribute of viscoelasticity for the second portion106. In some embodiments, an anisotropic medical grade polymer can beused for achieving a desired value of anisotropicity. In someembodiments, a creep resistant medical grade polymer can be used forachieving a desired value of creep resistance.

In some embodiments, the first bodily tissue can be stiffer and thesecond bodily tissue can be flexible, therefore the first portion 104 insuch cases can be configured with the biomechanical attributes congruentwith high stiffness and the second portion 106 with high flexibility.Similarly, in other embodiments, other attributes may be associatedaccording to the behavior of the respective bodily tissues. Thedifferent ways of achieving the desirable values for the biomechanicalattributes for the first portion 104 and the second portion 106 asdiscussed above can be used in isolation or in combination.

In some embodiments, for example, the second bodily tissue can be theanterior vaginal wall. Various examples of attributes possibly needed tobe considered for defining the portions of the first flap 102 that areattached to the anterior vaginal wall can without limitations beviscoelasticity, viscohyperelasticity, resistance to creep andanisotropy, and the like.

The first flap 102 further includes the transition region 108 asmentioned above. The transition region 108 defines a proximal portion126 and a distal portion 128. The proximal portion 126 of the transitionregion 108 can be coupled to or extend from the distal portion 124 ofthe second portion 106. The distal portion 128 of the transition region108 can be coupled to or extend from the proximal portion 114 of thefirst portion 104. In some embodiments, the transition region 108 maydefine a third type of knit structure (not shown here and explainedlater) that monolithically joins the first portion 104 and the secondportion 106. In some embodiments, the third knit structure may define athird type of pore construct (not shown here and explained later). Insome embodiments, the first flap 102 can be formed by suturing togetherthe first portion 104 and the second portion 106. In such cases, thetransition region 108 includes sutures tying the first portion 104 andthe second portion 106.

In some embodiments, the implant 100 further includes a second flap (notshown in FIG. 1). The second flap can include a first portion, a secondportion and a transition region. The first portion and the transitionregion of the second flap can function the same way as that of the firstflap 102 and can be defined in a similar manner. The first portion canbe attached to the first bodily tissue proximate to a location where thefirst portion 104 of the first flap 102 is attached. The second portionof the second flap can be configured to be attached to a third bodilytissue. In some embodiments, the third bodily tissue can be a posteriorvaginal wall inside a patient's body. The third bodily tissue exhibits adefinite biomechanical behavior in a defined set of physical conditions.The second portion can define the biomechanical attributes so as toemulate the biomechanical behavior of the third bodily tissue, where atleast a portion of the first portion of the second flap is required tobe attached, in the defined set of physical conditions. Thebiomechanical attributes can be defined by a third set of valuescorresponding to respective biomechanical parameters associated with thebiomechanical attributes. The second portion of the second flap can beconfigured so that at least one of the biomechanical parameters of thesecond portion 106 of the first flap and the second portion of thesecond flap differ in their numerical values. For example, the stiffnessbehavior of the anterior vaginal wall can be different from theposterior vaginal wall; therefore the second portion 106 of the firstflap 102 and the second portion of the second flap can be fabricated toexhibit stiffness attributes different from each other.

In some embodiments, the implant 100 can be configured such that each ofthe first flap 102 and the second flap define stripes of material andcan be configured to be attached separately to bodily locations. In someembodiments, each of the first flap 102 and the second flap areconstructed from a single piece of material. In some embodiments, thefirst flap 102 and the second flap are fabricated independent of eachother. In some embodiments, the implant 100 can be formed from a meshmaterial. In some embodiments, the implant can be formed from a non-meshmaterial.

In some embodiments, the implant 100 can be Y-shaped. The Y-shapedimplant can include three portions—a first portion configured to beattached to the sacrum or tissues proximate the sacrum, a second portionconfigured to be attached to the anterior vaginal wall, a third portionconfigured to be attached to the posterior vaginal wall. In someembodiments, the Y-shaped implant 100 can be fabricated so as to includeeither of the first flap 102 and the second flap as described above andanother flap which may be either a conventional strip of implantmaterial or any of the first flap and the second flap above. Forexample, in an embodiment, the Y-shaped implant can be fabricated byusing the first flap and the second flap and coupling them together toprovide a Y-shape to the implant. During fabrication a portion of thefirst and/or second flaps may be removed to configure the implant in theY-shape. For example, at least one of the first portion of the firstflap and the first portion of the second flap can be removed. In anotherembodiment, the Y-shaped implant can be fabricated by using one of thefirst flap and the second flap and another conventional flap such thatthe conventional flap can be coupled to the other of the first or thesecond flap to configure the implant in the Y-shape. In still anotherembodiment, the Y-shape can be achieved by using various portions of thefirst flap and the second flap and a conventional implant strip. In someembodiments, the biomechanical attributes of the three portions of theY-shaped implant can be defined based on the biomechanical behavior ofthe three locations of the body where the three portions of the implantare configured to be attached. In other embodiments, the implant has ashape other than a Y-shape. For example, the implant could berectangular, square, or any other shape. Additionally, in someembodiments, the implant has more than one portion, such as more thanone separate portion. For example, the implant may have two, three ormore separate portions or pieces.

In some embodiments, the implant 100, or the first flap 102 or thesecond flap can be cut from a prefabricated structure including thefirst portion 104 with the first type of knit structure and the secondportion 106 with the second type of knit structure. In some embodiments,the implant 100 can be fabricated by coupling different strips ofmaterials each defining a set of biomechanical attributes congruent withbiomechanical behavior of respective anatomical locations where they areplaced inside a patient's body. The strips can take a shape such aslinear or planar, curvilinear, curved, or any other shape.

In some embodiments, the first flap 102 and the second flap can bemonolithically defined as a single piece such as in the form of atubular structure (not shown here and explained later). The tubularstructure can include a first portion, a transition region and a secondportion. The first portion can be configured to be attached proximatethe sacrum inside a patient's body. In some embodiments, the firstportion can be similar to the first portion of the first flap describedabove in terms of biomechanical attributes. The transition regionextends from the first portion. In some embodiments, the second portionof the tubular structure can function in a manner similar to the way thesecond portion of the first flap and the second portion of the secondflap together perform. For example, an upper circumferential section ofthe second portion of the tubular structure can function similar to thefunction of the second portion of the first flap and the lowercircumferential section of the tubular structure can function similar tothe second portion of the second flap. In an embodiment, the secondportion of the tubular structure can be configured to be cut by anoperator to convert it into two sections. The sections though may stillbe joined at a medial portion or proximate the transition region. Insome embodiments, two slits may be provided along two lateral edges ofthe tubular structure to define the two flaps for the two differentbodily tissues. The slits can be made by an operator or may bepre-fabricated.

In some embodiments, the procedure of placing the implant 100 within abody can be performed after performing hysterectomy and removal ofuterus from the body. In some other embodiments, the implant 100 can beplaced even when the uterus is intact. The first flap 102 and the secondflap can be attached inside the patient's body through variousattachment elements or means. In some embodiments, the attachmentelements include, without limitations, sutures, adhesives, bondingagents, mechanical fasteners (e.g. a medical grade plastic clip),staples, and the like. In some embodiments, the implant 100 can besutured to bodily tissues with the use of a suturing device such as aCapio™ (as sold and distributed by Boston Scientific Corporation) andthe like. In some embodiments, the implant 100 can be delivered inside apatient's body using any suitable insertion tool such as a needle or anyother device. In some embodiments, a dilator may be attached to theimplant 100 to deliver the implant 100 inside the patient's body.

In various embodiments, as discussed above, the implant 100 is made of asingle piece of material. In some embodiments, the material issynthetic. In some embodiments, the implant 100 includes a polymericmesh body. Exemplary polymeric materials are polypropylene, polyester,polyethylene, nylon, PVC, polystyrene, and the like. In some otherembodiments, the implant 100 includes a polymeric planar body withoutmesh cells. In some embodiments, the implant 100 is made of a mesh bodymade of a non-woven polymeric material. An example of the mesh, out ofwhich the implant 100 is formed, can be Polyform® Synthetic Meshdeveloped by the Boston Scientific Corporation. The Polyform® SyntheticMesh is made from uncoated monofilament macro-porous polypropylene.Typically, the surface of the implant 100 is made smooth to avoid/reduceirritation on adjacent body tissues during medical interactions.Additionally, the implant 100 is stretchable and flexible to adaptmovements along the anatomy of the human body and reduce suture pullout.Furthermore, softness, lightness, conformity, and strength are certainother attributes that can be provided in the implant 100 for efficienttissue repair and implantation. In some embodiments, the implant 100 canbe made of natural materials such as biologic material or a cadaverictissue and the like. In some embodiments, the implants can be cut,stamped, shaped, or otherwise molded into a shape. Exemplary biologicmaterials are bovine dermis, porcine dermis, porcine intestinal submucosa, bovine pericardium, a cellulose based product, cadaveric dermis,and the like. Accordingly, the in some embodiments, the structures arenot knit structures. Rather, in some cases the structures are cut,stamped, or molded from sheets of material for example.

In some embodiments, different portions of the implant may be configuredto display or have different biomechanical profiles. For example, insome embodiments portions of the implant may include a coating, such asa silicone coating that may impart or provide elasticity factors to theportions of the implant. The coating may also secure or help prevent thefibers or filaments of the implant from moving with respect to eachother. In some embodiments, the coating may be configured to degrade orpartially degrade once disposed within the body of the patient. In someembodiments, portions of the implant may be annealed or softened withrespect to other portions of the implant. The annealing or softening canbe done in patterns to provide or impart anisotropic characteristics.For example, in some embodiments, heat, radiation, or chemicals may beused to anneal or soften portions of the implant.

In some embodiments, some filaments of the implant can be treated withglue or an adhesive or can be welded to an adjacent filament. Suchgluing or welding can provide different characteristics to the differentportions of the implant. In some embodiments, different materials may beused to form the different portions of the implant. The differentmaterials may be configured to display and provide differentcharacteristics to the different portions of the implant. In someembodiments, the different portions of the implant may include morefilaments or more twists or have a different weave pattern.

In some embodiments, the implant includes a reinforcing fiber or aplurality of reinforcing fibers. The reinforcing fiber or fibers may bedisposed at specific locations or extend along a particular direction toprovide different characteristics to the different portions of theimplant.

In some embodiments, the implant includes flat or planar sheets ofmaterial. The sheets of material may have different pore quantities ordistributions to provide different characteristics at different portionsof the implant. In some embodiments, the implant may include laminatedmaterials. For example, a mesh material may be coupled to or otherwisedisposed adjacent to a sheet material. Additionally, one sheet materialmay be coupled to or otherwise disposed adjacent to another sheetmaterial.

In some embodiments, a portion or portions of the implant may beweakened to provide different characteristics to different portions ofthe implant. For example, in some embodiments, portions of the implantsmay be notched, scored, or shaved (or apertures may be formed) tointroduce weakness or to weaken different portions of the implant.

In some embodiments, the implant includes a sheet of material that has aproperty or a mechanical parameter that varies. For example, in oneembodiment, the sheet of material has a property or biomechanicalproperty, such as ability to stretch, of one value at a first locationon the sheet of material and has the property or mechanical parameter ofanother value at different location on the sheet of material. In someembodiments, the property or mechanical parameter varies along a lengthof the sheet of material. In some embodiments, the property ormechanical parameter is the stiffness of the material, the ability toflex or stretch, or any other property or mechanical parameter.

In some embodiments, the varying of the property or mechanical parameteris accomplished by varying the knit pattern of the sheet of material. Inother words, in some embodiments, the single sheet of material may havedifferent properties or mechanical parameter at different locationsbecause of or at least in part because of different knit patters or knitdensities at the different locations along the sheet of material. Forexample, the sheet of material may have a first knit pattern at a firstlocation on the sheet of material and a second knit pattern at a secondlocation on the sheet of material.

In some embodiments, the weight or density of the sheet of material isgreater than or equal to 30 grams per square meter (g/m²). For example,the weight of the material may be between 30 and 40 g/m². In otherembodiments, the weight of the material is greater than 40 g/m². In yetother embodiments, the weight of the material is less than 30 g/m². Insome embodiments, the weight of the material varies at differentlocations on the sheet of material. For example, in some embodiments,the weight of the material may be greater than 30 g/m² at one locationand less than 30 g/m² at another location.

FIG. 2 is a perspective view of a first flap 248 of a medical implant200 for placement over an anterior wall of a vagina inside a patient'sbody. The first flap 248 can include a first portion 202, a secondportion 204 and a transition region 206.

The first portion 202 defines a first side 208, a second side 210, aproximal portion 212 and a distal portion 214. The proximal portion 212can be attached to or extend from the transition region 206 of the firstflap 248. The distal portion 214 can be configured to be attached to afirst bodily tissue. In some embodiments, the first bodily tissue can bea sacrum inside a patient's body. The first portion 202 defines a lengthL5 along the first side 208 extending from the proximal portion 212 tothe distal portion 214. The first portion 202 defines a length L6 alongthe second side 210 extending from the proximal portion 212 to thedistal portion 214. In some embodiments, the length L5 can be equal tothe length L6. The first portion 202 defines a width W3 extendingbetween the first side 208 and the second side 210. In some embodiments,the width W3 can remain constant from the proximal portion 212 to thedistal portion 214.

In some embodiments, the first flap 248 can be configured so that thefirst portion 202 can be attached to the sacrum or tissues proximate thesacrum and the remaining portion of the first flap 248 can be attachedto the anterior vaginal wall in order to provide support to the anteriorvaginal wall.

The first bodily tissue exhibits a definite biomechanical behavior in adefined set of physical conditions. The first portion 202 can beconfigured to define a set of biomechanical attributes or biomechanicalproperties so as to emulate the biomechanical behavior of the firstbodily tissue, where at least a portion of the first portion 202 isrequired to be attached, in the defined set of physical conditions. Thebiomechanical attributes can be defined by a first set of values ofrespective biomechanical parameters associated with the biomechanicalattributes. For example, in some embodiments, the biomechanicalattribute can be elasticity and a corresponding biomechanical parametercan be modulus of elasticity, which can be defined by a numerical value.In some embodiments, the biomechanical attribute can be stiffness. Insome embodiments, the biomechanical attribute can be strength. In someembodiments, the biomechanical attribute can be resistance to creep. Invarious embodiments, the biomechanical attributes of the first portion202 can be defined by defining one or more of shape, size, fabricationmethod or structure, profile, knit structure, pore size, material offabrication, and the like. In some embodiments, for example, thecongruence between the biomechanical behavior of the first bodily tissueand the first portion 202 can be achieved by varying the shape of thefirst portion 202. For example, the first portion 202 can have a square,rectangular, triangular or any other shape, which can facilitate thefirst portion 202 in closely equating the biomechanical behavior of thefirst bodily tissue.

In some embodiments, the values of the biomechanical attributes of thefirst portion 202 can be defined by a first type of knit structure 216.In some embodiments, the first type of knit structure 216 can be definedby a first type of knitting pattern 218. In some embodiments, the firsttype of knit structure 216 can be defined by weaving the knit with arequired and defined tension. For example, the first type of knittingpattern 218 can be woven tightly or loosely to define a required type ofknitting pattern. In some embodiments, the first type of knittingpattern 218 characterized by biomechanical properties of high elasticmodulus and stiffness can hold bodily tissue such as a vaginal tissue inthe correct anatomical location. In some embodiments, the first type ofknit structure 216 can be defined by a first type of pore construct 220.The first type of pore construct 220 includes a plurality of pores 222.The first type of pore construct 220 can be fabricated to definebiomechanical attributes conforming to biomechanical behavior of thefirst bodily tissue by varying the first type knit structure 216, andthe pore construct 220. The different ways of achieving the desirablebiomechanical attributes for the first portion 202 of the first flap 248can be used in isolation or in combination. In some embodiments, theknit structure includes knitting, weaving, braiding, twisting, tying, orany combination thereof. Utilizing materials with properties that changeover time, such as biodegradable materials, can adjust specificbiomechanical properties over time. Coatings on specific portions of theimplant may be used to influence the biomechanical properties, forexample but reducing the elasticity of the coated portion.

It must be appreciated that though the above ways of defining therequired biomechanical attributes are used for mesh-based implants 200including a knit pattern, the implant 100 can be fabricated as a planarstructure. In such embodiments, the biomechanical attributes of thefirst portion 202 of the first flap 248 can be defined for example bythe material used in fabrication of the first portion 202, shape andsize of the portion, and the like without limitations. For example, arigid medical grade polymer can be used for fabricating the firstportion 202 thereby defining the biomechanical attribute of rigidity forthe first portion 202 to a desired value.

The second portion 204 defines a first side 224, and a second side 226,a proximal portion 228 and a distal portion 230. The distal portion 230can be attached to or extend from the transition region 206 of the firstflap 248. The proximal portion 228 can be configured to be attached tothe second bodily tissue. In some embodiments, the second bodily tissuecan be an anterior vaginal wall inside a patient's body.

The second portion 204 defines a length L7 along the first side 224extending from the proximal portion 228 to the distal portion 230. Thesecond portion 204 defines a length L9 along the second side 226extending from the proximal portion 228 to the distal portion 230. Insome embodiments, the length L7 can be different from the length L9. Thesecond portion 204 defines a width W4 extending between the first side224 and the second side 226. In some embodiments, as illustrated, thewidth W4 can differ from the proximal portion 228 to the distal portion230. In some embodiments, the second portion 204 is fabricated such thatthe width W4 is greater than the width W3 of the first portion 202. Insome embodiments, the second portion 204 can define a trapezoidal shapesuch that the width W4 at the proximal portion 228 is substantiallygreater than the width W4 at the distal portion. The second portion isconfigured to be attached and provide support to a second bodily tissue.

The second bodily tissue exhibits a definite biomechanical behavior in adefined set of physical conditions. The behavior exhibited by the secondbodily tissue can be different than the behavior exhibited by the firstbodily tissue. The second bodily tissue can be configured to define aset of biomechanical attributes or biomechanical properties so as toemulate the biomechanical behavior of the second bodily tissue in thedefined set of physical conditions. The biomechanical attributes can bedefined by a second set of values of respective biomechanical parametersassociated with each of the biomechanical attributes. The second set ofvalues can be different from the first set of values. Consequently, thesecond portion 204 may be defined to exhibit values of the biomechanicalattributes, different than the values of the biomechanical attributes ofthe first portion 202, in accordance with the second bodily tissue whereat least a portion of the second portion 204 of the first flap 248 maybe attached. It must be appreciated that in some embodiments, only oneor more but not all of the first set of values biomechanical attributesand the second set of values differ in terms of their values ofparameters defining the respective attributes. For example, the modulusof elasticity may be same for the first portion 202 and the secondportion 204 but any other parameter for other attribute such asresistance to creep may be different. In some other embodiments, all theattributes of the first portion 202 and the second portion 204 maydiffer in terms of their values of parameters defining the respectiveattributes. The values of the various parameters provide mathematicalmeasures of the respective parameters.

In some embodiments, the second set of values associated with thebiomechanical attributes can be different along different directions forthe same fixed set of physical conditions even for the same attribute.For example, in some embodiments, a value of a parameter P defining anattribute T along a first direction B1 can be different from a value ofthe parameter P defining the attribute T along a second direction B2. Insome embodiments, the first direction B1 can be a longitudinal directionand the second direction B2 can be a transverse direction. Therefore, aparameter may differ in its value in different directions, in someembodiments. For example, modulus of elasticity of various portions ofthe first flap 248 may differ in different directions, in someembodiments. This may be important to match the biomechanical behaviorof bodily tissues that may exhibit different levels of elasticity indifferent directions. Also, the second set of values associated with thebiomechanical attributes can vary with a variation in the set ofphysical conditions. However, in some embodiments, the physicalconditions may vary and measurement of the biomechanical behavior andthe attributes may accordingly be calibrated so as to compare thevarious values associated with the various attributes in light of therequired characteristics at the required locations. In some embodiments,the first direction B1 and the second direction B2 do not align alongthe axes of the implant. Additionally, in some embodiments, B1 and B2are not disposed orthogonal or perpendicular to one another.

In some embodiments, the biomechanical attributes can include elasticityand a corresponding biomechanical parameter can be modulus ofelasticity. In some embodiments, the biomechanical attribute can beviscoelasticity. In some embodiments, the biomechanical attribute can beviscohyperelasticity. In some embodiments, the biomechanical attributecan be anisotropicity. In various embodiments, the biomechanicalattributes of the second portion 204 can be defined by defining one ormore of shape, size, fabrication method or structure, profile, knitstructure, pore size, material of fabrication, and the like. In someembodiments, for example, the congruence between the biomechanicalbehavior of the second bodily tissue and the second portion 204 can beachieved by varying the shape of the second portion 204. For example,the trapezoidal shape of the second portion 204 can conform to the shapeof the second bodily tissue such as the anterior vaginal wall. Thetrapezoidal shape can be provided to the second portion 204 to emulate ataper of an outer vaginal canal. In some embodiments, at the widest end,the width W4 can range from 21.7-55 mm. In some embodiments, at thenarrowest end, the width W4 can range from 18.7-37 mm. The lengths L6 orL8 of the trapezoid can range from 40.8-95 mm based on the linear lengthof the vagina.

In some embodiments, the values of the biomechanical attributes of thesecond portion 204 can be defined by a second type of knit structure232. In some embodiments, the second type of knit structure can bedefined by a second type of knitting pattern 234. In some embodiments,the second type of knit structure 232 can be defined by weaving the knitwith a required and defined tension. For example, the anterior vaginalwall shows biomechanical behavior of anisotrophicity, with bias towardmore elongation along a transverse direction such as the direction B1,therefore, the second type of knitting pattern 234 can be selected so asto be more elastic along a longitudinal direction such as the directionB2 as compared to the transverse direction.

In some embodiments, the second type of knit structure 232 can bedefined by a second type of pore construct 236. In some embodiments, thesecond type of pore construct 236 is different from the first type ofpore construct 220. The second type of pore construct 236 includes aplurality of pores 238. In some embodiments, the difference in poreconstruct for the first portion 202 and the second portion 204 can beachieved by weaving or knitting a mesh with different pore sizes. Insome embodiments, the difference in pore constructs 220 and 236 of thefirst portion 202 and the second portion 204 can be achieved byextruding or knitting a single pore size mesh and heat setting the poresto set a different pore size for the first portion 202 and the secondportion 204 as illustrated and described by later figures. The secondpore construct 236 can define the second set of values of thebiomechanical attributes of the second portion 204. In an embodiment,the second pore construct 236 can define larger pore sizes as comparedto the remaining portion of the first flap 248. In some embodiments, thesecond pore construct 236 can be fabricated to exhibit biomechanicalattributes of high flexibility and elongation to a particular strainlevel and high stiffness after a particular stain level is reached. Sucha strain behavior closely emulates the biomechanical behavior of theanterior vaginal wall.

In some embodiments, one or more of the biomechanical attributes can bedefined by a material used for fabricating the second portion 204. Forexample, a viscoelastic medical grade polymer can be used forfabricating the second portion 204 thereby defining a value for thebiomechanical attribute of viscoelasticity for the second portion 204.In some embodiments, an anisotropic medical grade polymer (or thefabrication of such material) can be used for achieving a desired valueof anisotropicity. In some embodiments, a creep resistant medical gradepolymer can be used for achieving a desired value of creep resistance.

Generally, the anterior vaginal wall can be viscohyperelastic. Thesecond portion therefore can be defined such that it exhibits highviscoelasticity. In some embodiments, the biomechanical parameters canhave different values in different directions. For example, thebiomechanical parameters may have different values in the firstdirection B1 than in the second direction B2.

The values of the biomechanical parameters defining the biomechanicalbehavior of the anterior vaginal wall may vary under different loadconditions. For example, in some embodiments, the stiffness of theanterior vaginal wall at a low strain along the direction B1 can rangefrom 0.431-4.15 MegaPascal (MPa). In some embodiments, the stiffness ofthe anterior vaginal wall at a high strain along the direction B1 canrange from 5.15-17.28 MPa, In some embodiments, the stiffness theanterior vaginal wall at the low strain along the direction B2 can rangefrom 0.385-0.415 MPa. In some embodiments, the stiffness of the anteriorvaginal wall along the direction B2 at the high strain can range from0.370-0.61 MPa. The stiffness behaviors of the anterior vaginal wall arefurther explained in detail in conjunction with FIGS. 6A and 6B.Therefore, in some embodiments, the second portion 204 of the first flap248 can be fabricated so as to define a set of values of thebiomechanical parameter of stiffness that can conform to the valuesdefining the biomechanical behavior of the anterior vaginal wall undersimilar load conditions.

The first flap 248 further includes the transition region 206 asmentioned above. The transition region 206 defines a proximal portion240 and a distal portion 242. The proximal portion 240 can be coupled toor extend from the distal portion 230 of the second portion 204. Thedistal portion 242 can be coupled to or extend from the proximal portion212 of the first portion 202. In some embodiments, the transition region206 may define a third type of knit structure 244 that monolithicallyjoins the first portion 202 and the second portion 204. In someembodiments, the third knit structure 244 may define a third type ofpore construct 246. In some embodiments, the first flap 248 can beformed by suturing together the first portion 202 and the second portion204. In such cases, the transition region 206 includes sutures tying thefirst portion 202 and the second portion 204.

FIG. 3 is a perspective view of a second flap 340 of the medical device200 for placement over a posterior wall of a vagina inside a patient'sbody. The first flap 248 and the second flap 340 can collectively formthe medical implant 200. The second flap 340 can include a first portion302, a second portion 304 and a transition region 306.

The first portion 302 defines a first side 308, a second side 310, aproximal portion 312 and a distal portion 314. The proximal portion 312can be attached to or extend from the transition region 306 of thesecond flap 340. The distal portion 314 can be configured to be attachedto a first bodily tissue. In some embodiments, the first bodily tissuecan be a sacrum or tissues proximate the sacrum. The first portion 302defines a length L9 along the first side 308 extending from the proximalportion 312 to the distal portion 314. The first portion 302 defines alength L10 along the second side 310 extending from the proximal portion312 to the distal portion 314. In some embodiments, the length L9 can beequal to the length L10. The first portion 302 defines a width W5extending between the first side 308 and the second side 310. In someembodiments, the width W5 can remain constant from the proximal portion312 to the distal portion 314.

In some embodiments, the second flap 340 can be configured so that thefirst portion 302 can be attached to the sacrum and the remainingportion of the implant 300 can be attached to the posterior vaginal wallin order to provide support to the posterior vaginal wall. The firstbodily tissue exhibits a definite biomechanical behavior in a definedset of physical conditions. The first portion 302 can be configured todefine a set of biomechanical attributes or biomechanical properties soas to emulate the biomechanical behavior of the first bodily tissue,where at least a portion of the first portion 302 is required to beattached, in the defined set of physical conditions. The first portion302 of the second flap 340 can be fabricated similar to the firstportion 202 of the first flap 248 as described in FIG. 2. The attributesof the first portion 302 of the second flap 340 can be defined in amanner similar to the attributes of the first portion 202 of the firstflap 248.

The second portion 304 defines a first side 316, and a second side 318,a proximal portion 320 and a distal portion 322. The distal portion 322can be attached to or extend from the transition region 306 of thesecond flap 340. The proximal portion 320 can be configured to beattached to a third bodily tissue. In some embodiments, the third bodilytissue can be the posterior vaginal wall.

The second portion 304 defines a length L11 along the first side 316extending from the proximal portion 320 to the distal portion 322. Thesecond portion 304 defines a length L12 along the second side 318extending from the proximal portion 320 to the distal portion 322. Insome embodiments, the length L11 can be different from the length L12.The second portion 304 defines a width W6 extending between the firstside 316 and the second side 318. In some embodiments, as illustrated,the width W6 can differ from the proximal portion 320 to the distalportion 322. In some embodiments, the second portion 304 is fabricatedsuch that the width W6 is greater than the width W5 of the first portion302. In some embodiments, the second portion 304 can define atrapezoidal shape such that the width W6 at the proximal portion 320 issubstantially greater than the width W6 at the distal portion 322.

The third bodily tissue exhibits a definite biomechanical behavior in adefined set of physical conditions. The behavior exhibited by the thirdbodily tissue can be different than the behavior exhibited by the firstbodily tissue or the second bodily tissue. The third bodily tissue canbe configured to define the biomechanical attributes or biomechanicalproperties so as to emulate the biomechanical behavior of the thirdbodily tissue in the defined set of physical conditions. Thebiomechanical attributes can be defined by a third set of values ofrespective biomechanical parameters associated with the biomechanicalattributes. In some embodiments, the third set of values can bedifferent from the first set of values of the biomechanical attributes.In some embodiments, the third set of values can be different from thesecond set of values of the biomechanical attributes. Consequently, thesecond portion 304 may be defined to exhibit biomechanical attributes,different than the biomechanical attributes of the first portion 302, inaccordance with the third bodily tissue where at least a portion of thesecond portion 304 may be attached. The second portion 304 may bedefined to exhibit biomechanical attributes, different than thebiomechanical attributes of the first portion 202 from the first flap248.

In some embodiments, the third set of values associated with thebiomechanical attributes can be different along different directions forthe same fixed set of physical conditions even for the same attribute.For example, in some embodiments, a value of a parameter P defining anattribute T along a first direction C1 can be different from a value ofthe parameter P defining the attribute T along a second direction C2. Insome embodiments, the first direction C1 can be a longitudinal directionand the second direction C2 can be a transverse direction. Also, thethird set of values associated with the biomechanical attributes canvary with a variation in the set of physical conditions. In someembodiments, the third set of values can be different from the first setof values associated with the biomechanical attributes under the samefixed set of physical conditions.

In some embodiments, the biomechanical attribute can include elasticityand a corresponding biomechanical parameter can be modulus ofelasticity. In some embodiments, the biomechanical attribute can beviscoelasticity. In some embodiments, the biomechanical attribute can beviscohyperelasticity. In some embodiments, the biomechanical attributecan be anisotropicity. In various embodiments, the biomechanicalattributes of the second portion 304 can be defined by defining one ormore of shape, size, fabrication method or structure, profile, knitstructure, pore size, material of fabrication, and the like. In someembodiments, for example, the congruence between the biomechanicalbehavior of the third bodily tissue and the second portion 304 can beachieved by varying the shape of the second portion 304. For example,the trapezoidal shape of the second portion 304 can conform to shape ofthe posterior vaginal wall.

In some embodiments, the values of the biomechanical attributes of thesecond portion 304 can be defined by a fourth type of knit structure324. In some embodiments, the fourth type of knit structure 324 can bedefined by a fourth type of knitting pattern 326. In some embodiments,the fourth type of knit structure 324 can be defined by weaving the knitwith a required and defined tension. For example, the posterior vaginalwall shows biomechanical behavior of anisotrophicity, with biasness (orbeing biased) toward more elongation along the direction C1, therefore,the fourth type of knitting pattern 326 can be selected to be moreelastic along the direction C2 as compared to the direction C1.

In some embodiments, the fourth type of knit structure 324 can bedefined by a fourth type of pore construct 328. In some embodiments, thefourth type of pore construct 328 is different from the first type ofpore construct 220 and the second type of pore construct 236 of FIG. 2.The fourth type of pore construct 328 includes a plurality of pores 330.The difference in pore construct for the first portion 302 and thesecond portion 304 can be achieved as described in FIG. 2. The fourthtype of pore construct 328 can be configured to conform to biomechanicalproperties of the posterior vaginal wall.

In some embodiments, one or more of the biomechanical attributes can bedefined by the third set of values associated with the biomechanicalattributes for the second portion 304. In an embodiment, the third setof values may be defined by a material used for fabricating the secondportion 304. For example, a viscoelastic medical grade polymer can beused for fabricating the second portion 304 thereby defining a desiredvalue of viscoelasticity for the second portion 304. In someembodiments, an anisotropic medical grade polymer can be used forachieving a desired value of anisotropicity. In some embodiments, acreep resistant medical grade polymer can be used for achieving adesired value of creep resistance.

The posterior vaginal wall can have high visco-hyper elasticity.Therefore, the second portion 304 can have a high value ofviscohyperelasticity under a fixed set of stress conditions. In someembodiments, the value of the biomechanical parameter can be differentfor the first direction C1 and the second direction C2 for the posteriorvaginal wall. The value of the biomechanical parameter would bedifferent for a set of high load conditions and a set of low loadconditions for the posterior vaginal wall. For example, in someembodiments, the stiffness of the posterior vaginal wall at a low strainalong the direction C1 can range from 0.46-0.98 MegaPascal (MPa). Insome embodiments, the stiffness of the posterior vaginal wall at a highstrain along the direction C1 can range from 2.49-9.08 MPa. In someembodiments, the stiffness of the posterior vaginal wall at the lowstrain along the direction C2 can range from 1.14-1.46 MPa. In someembodiments, the stiffness of the posterior vaginal wall along thedirection C2 at the high strain can range from 2.39-3.83 MPa. Thesevalues indicate an anisotropic behavior and stiffness variation alongdifferent directions and different physical conditions for posteriorvaginal wall. The stiffness behaviors of the posterior vaginal wall areexplained in detail by FIGS. 6A and 6B. Therefore, in some embodiments,the second portion 304 of the second flap 340 can be fabricated so as todefine a set of values of the biomechanical parameter of stiffness thatcan conform to the values defining the biomechanical behavior of theposterior vaginal wall under similar load conditions. The second portion304 can be fabricated such that the set of values of the biomechanicalparameter can be different from the set of values for the samebiomechanical parameter of the second portion 204 of the first flap 248.

The second flap 340 further includes the transition region 306 asmentioned above. The transition region 306 defines a proximal portion332 and a distal portion 334. The proximal portion 332 can be coupled toor extend from the distal portion 322 of the second portion 304. Thedistal portion 334 can be coupled to or extend from the proximal portion312 of the first portion 302. In some embodiments, the transition region306 defines a fifth type of knit structure 336 that monolithically joinsthe first portion 302 and the second portion 304. The fifth type of knitstructure 336 defines a fifth pore construct 338. In some embodiments,the third knit structure 244 may define a third type of pore construct246.

In some embodiments, the second flap 340 can be made out of a singlestrip of material. In some embodiments, the second flap 340 can beformed by suturing together the first portion 302 and the second portion304. In such cases, the transition region 306 includes sutures tying thefirst portion 302 and the second portion 304.

FIG. 4 is a perspective view of a medical implant 400 including aplurality of flaps for placement over the first bodily tissue, thesecond bodily tissue and the third bodily tissue inside a patient'sbody. The plurality of flaps may include a first flap 402, a second flap404, and a third flap 406. The plurality of flaps can be joined togetherat a transition region 408 to form a Y-shaped implant as illustrated inthe FIG. 4. In some embodiments, there may not be any transition regionssuch as the transition region 408 and the first, second, and third flapscan directly be coupled with the use of sutures or any other coupler.

The first flap 402 defines a proximal portion 420 and a distal portion422. The proximal portion 420 can be attached to or extend from thetransition region 408 of the medical implant 400. The distal portion 422can be configured to be attached to the first bodily tissue as describedwith reference to FIG. 2. The first flap 402 can be configured to definethe first set of values corresponding to the biomechanical parameters asexplained in FIG. 2 for emulating biomechanical behavior of first bodilytissue for example the sacrum, or tissue proximate the sacrum.

The second flap 404 defines a proximal portion 424 and a distal portion426. The proximal portion 424 can be attached to or extend from thetransition region 408 of the medical implant 400. The distal portion 426can be configured to be attached to the second bodily tissue asdescribed with reference to FIG. 2. The second flap 404 can beconfigured to define the second set of values corresponding to thebiomechanical parameters as explained in FIG. 2 for emulatingbiomechanical behavior of the second bodily tissue for example, theanterior vaginal wall.

The third flap 406 defines a proximal portion 428 and a distal portion430. The proximal portion 428 can be attached to or extend from thetransition region 408 of the medical implant 400. The distal portion 430can be configured to be attached to the third bodily tissue as describedwith reference to FIG. 3. The third flap 406 can be configured to definethe third set of values corresponding to the biomechanical parameters asexplained in FIG. 3 for emulating biomechanical behavior of third bodilytissue, for example, the posterior vaginal wall.

In some embodiments, the first flap 402, the second flap 404 and thirdflap 406 can be fabricated independent of each other. The first flap402, the second flap 404 and the third flap 406 can be tied togetherwith a suture 432 at the transition region 408 to form the medicalimplant 400. In some embodiments, the three flaps 402, 404, and 406exhibit different biomechanical attributes owning to differentbiomechanical properties of anatomical locations that each of the threeflaps 402, 404, and 406 are configured to be attached to.

As mentioned above, the biomechanical properties of the posterior wallof vagina, the anterior wall of vagina and the sacrum or tissuesproximate the sacrum inside a patient's body are different from eachother; therefore in some embodiments the flaps of the medical implant400 are fabricated with a pore construct and knit structure that canclosely mimic biomechanical attributes of the anatomical locationsinside the patient's body. For example, the first flap 402 can have aknit structure 410 similar to the first knit structure 216 of the firstportion 202 of the first flap 248 from FIG. 2 so as to bebiomechanically congruent with the first bodily tissue. The second flap404 can have a knit structure 412 similar to the second knit structure232 of the second portion 204 of the first flap 248 from FIG. 2 so as tobe biomechanically congruent with the second bodily tissue. The thirdflap 406 can have a knit structure 414 similar to the fourth knitstructure 324 of the second flap 340 from FIG. 3 so as to bebiomechanically congruent with the third bodily tissue. Upon placement,the first flap 402, the second flap 404, and the third flap 406 can actas three different arms that can be configured to support the pelvicorgans like the anterior vaginal wall, the posterior vaginal wall andthe sacrum by attaching the implant 400 at three distinct bodilylocations. The three arms can be movable with respect to one another toconform to the shape of the target anatomical location of attachmentinside the body. The three arms can take a shape such as linear/planar,curvilinear, curved, or any other shape.

In some embodiments, for example, the medical implant 400 can be formedby tying together the second portion 204 of the first flap 248, thesecond portion 304 of the second flap 340 and the first portion 202 or302 from either the first flap 348 or the second flap 340. In suchcases, the three portions mentioned above conform to the biomechanicalattributes of the second bodily tissue, the third bodily tissue and thefirst bodily tissue respectively.

In some embodiments, a Y-shaped mesh as illustrated in FIG. 4 may beformed of two sheets of material. One sheet of material may be coupled,such as via a suture or other coupling member or mechanism, to the othersheet of material to form a Y shape. In some embodiments, one of thesheets of material may have properties or mechanical parameters thatvary along a length of the sheet of material.

For example, in one embodiments, a first sheet of material may be placedin the body of the patient such that it extends from the sacrum (ortissues proximate the sacrum) of the patient to a vaginal wall of thepatient (or tissue proximate a vaginal wall), such as the posteriorvaginal wall of the patient. The portion of the first sheet of materialthat is coupled to the sacrum (or to tissue proximate the sacrum) mayhave a first value for a property or mechanical parameter. The portionof the first sheet of material that is coupled to the vaginal wall mayhave a different value for the property or mechanical parameter. In someembodiments, the property or mechanical parameter is stretchiness orability to stretch. In some embodiments, the portion of the first sheetof material that is coupled to the sacrum (or to tissues proximate thesacrum) is less stretchy (has less ability to stretch) than the portionof the sheet of material that is coupled to the vaginal wall.

In some embodiments, the second sheet of material that is coupled to thefirst sheet of material is configured to be coupled to another vaginalwall, such as an anterior portion of the vaginal wall (or tissuesproximate such vaginal wall). In some embodiments, the second sheet ofmaterial has the same value for the property or mechanical parameter asthe portion of the first sheet of material that is coupled to thevaginal wall.

In some embodiments, the first sheet of material may be rectangular,square, or any other shape. In some embodiments, the first sheet ofmaterial may be cut or reshaped by the user or the physician. In someembodiments, the first sheet of material is rectangular in shape and is20 cm by 52 cm in size. In other embodiments, the first sheet ofmaterial is larger than 20 cm by 52 cm. In yet other embodiments, thefirst sheet of material is smaller than 20 cm by 52 cm. In someembodiments, half of the first sheet of material is formed such that ithas a first value for a property or mechanical parameter and the otherhalf of the first sheet of material is formed such that it has a secondvalue for the property or mechanical parameter. For example, in someembodiments, a 20 cm by 26 cm portion of the first sheet of material mayhave the first value for the property or mechanical parameter andanother 20 cm by 26 cm portion of the first sheet of material may havethe second value for the property or mechanical parameter. In otherembodiments, more or less than half of the first sheet of material hasthe first value for the property or mechanical parameter. Accordingly,less or more than half of the first sheet of material has the secondvalue for the property or mechanical parameter.

In some embodiments, the portion of the first sheet of material that iscoupled to the vaginal wall of the patient may be formed of a knitstructure that has a high elongation (or is configured to elongate orstretch) at loads in the range of between 0 and 5 pounds of pressure.For example, the knit structure may be configured to stretch when placedunder loads of 0 to 5 pounds per square cm. In other embodiments, theportion of the first sheet of material that is coupled to the vaginalwall of the patient may be formed of a structure that is configured toelongate at higher amounts of pressure.

In some embodiments, a portion of the first sheet of material isformulated or configured to promote tissue ingrowth. For example, insome embodiments, the first portion of the first sheet of material isconfigured to promote tissue ingrowth. In some embodiments, the secondportion of the first sheet of material is configured to promote tissueingrowth.

FIG. 5A is a perspective view of a medical implant 500 formed as atubular structure 502.

The tubular structure 502 of the medical implant includes a firstportion 504, a second portion 506, and a transition region 510. Thetransition region 510 is formed from intersection of the first, and thesecond 504, and 506 of the tubular structure 502 of the medical implant500. The medical implant 500 defines a proximal portion 512, a distalportion 514 and a lumen 516 extending from the proximal portion 512 tothe distal portion 214. The medical implant 500 defines a length L13from the proximal portion 512 to the distal portion 514. The medicalimplant includes the second portion 506 at the proximal portion 512 ofthe medical implant. The second portion can a first section 524 and asecond section 508 and two slits 518A and 518B extending laterally alongthe length L13 of the medical implant 500. In some embodiments, theproximal portion 512 includes two slits extending laterally along thelength L13 and into the lumen 516 of the medical implant 500. The slits518A and 518B can configure first section 524 as apart from the secondsection 508 at a proximal end 534 of the medical implant 500. Themedical implant 500 can be configured so that each of the first portion504, the first section 524 and the second section 508 can define a setof biomechanical attributes, which can be congruent with the sacrum ortissues proximate the sacrum, the anterior vaginal wall and theposterior vaginal wall respectively. The congruency can be achieved byany of the methods described with reference to FIGS. 2-3.

The first portion 504 can define a knit structure 520 formed of a poreconstruct 522. In some embodiments, the pore construct 522 can define apore size so as to accommodate values of the biomechanical attributesthe first bodily tissue. The first section 524 can define a knitstructure 526 formed of a pore construct 528. In some embodiments, thepore construct 528 can define a pore size so as to accommodate values ofthe biomechanical attributes the second bodily tissue. The secondsection 508 can define a knit structure 530 formed of a pore construct532. In some embodiments, the pore construct 532 can define a pore sizeso as to accommodate values of the biomechanical attributes the thirdbodily tissue. In some embodiments, the knit structure 520 of the firstportion 504 is different from the knit structure 526 and the knitstructure 530 of the first section 524 and the second section 508 of thesecond portion 506. In some embodiments, the knit structure 526 of thefirst section 524 is different from the knit structure 530 of the secondsection 508. In some embodiments, the varying knit structure is formedby varying the knit structure in the course of a pore.

In some embodiments, the first portion 504 can be configured forattaching to the sacrum, the first section 524 to the anterior vaginalwall and the second section 508 to the posterior vaginal wall. In someembodiments, a value corresponding to a biomechanical parameter defininga biomechanical attribute of the first section 524 attaching to theanterior vaginal wall is different from a value of the samebiomechanical parameter of the second section 508 attaching to theposterior vaginal wall. For example, the value of elasticity can bedifferent for the first section 524 and the second section 508 undersimilar strain conditions.

In some embodiments, the medical implant 500 can be formed from aprocess of extrusion. The pore constructs 522, 528, and 532, in suchcases can be the same. The medical implant can then be provided a heattreatment and different portions of the medical implant 500 can be heatset to different pore sizes. For example, the pore construct 522 canremain in a closed position without application of heat as illustratedin FIG. 5B. The second portion 506 can be manually stretched to bringthe medical implant 500 in an open position as illustrated in FIG. 5C.This can increase a pore size of the pore constructs 528 and 532. Thepore construct 528 and the pore construct 532 can remain in an openposition on application of heat over the first section 524 and thesecond section 508. The first section 524 and the second section 508 mayeach be given heat treatment for setting different pore sizes so as tofacilitate defining biomechanical attributes emulating biomechanicalbehavior of the anterior and posterior vaginal walls respectively.

In some embodiments, the medical implant 500 can be fabricated so thatthe first portion 504 includes the knit structure 216 and the poreconstruct 220 as described for the first flap 248, the second portion506 includes the knit structure 232 and the pore construct 236 asdescribed for the first flap 248 and the third portion 508 includes theknit structure 324 and the pore construct 328 as described for thesecond flap 340.

FIG. 6A is an exemplary graphical representation of relationship betweenstress applied on a vaginal tissue and resulting elongation in thevaginal tissue due to the applied stress. A medical implant can befabricated to conform to the changes resulting in the vaginal tissue dueto applied stress. The medical implant can be any of the medicalimplants 200, 300, 400, and 500. The vaginal tissue is generallyviscoelastic or viscohyperelastic. The vaginal tissue can experiencelarge deformation under small loads as shown. Therefore, in someembodiments, the medical implant is configured to experience varyinglevels of deformation under varying loads. The vaginal tissuestress-strain or load vs (or compared to) elongation relationship canfollow a non-linear curve as illustrated. The curve has a first linearphase at low loads/stresses. At low levels of load, the strains orelongations are high defining a low stiffness attribute of the implant.The curve includes a second phase defined by a transition phase after aninflection point where it transitions from one linear phase to a thirdphase such that the curve is sharper in the third phase. The third phasedefines a region of relatively lower elongation even under anapplication of relatively higher loads as compared to the first phase.That is to say that that after the load increases after a limit definedby the inflection point, there is lesser elongation with every unitchange in load. This defines a property of high stiffness of the implantat higher loads. The unit change in elongation with every unit change inload decreases thereafter till it reaches a level that there is almostnegligible elongation in the implant even at increased loads. Theimplant thus behaves as a stiff member. Therefore, the medical implantcan be configured to define the attributes congruent with thestress-strain or load vs (or compared to) elongation relationship of thevaginal tissue. In some embodiments, the portion of the medical implantattaching to the anterior or posterior portion of the vagina can be soconfigured that it experiences large deformations over small loads untilthe inflection point is achieved. As the load is increased beyond theinflection point, the medical implant portion attached to the anteriorvaginal wall or posterior vaginal wall starts exhibiting high stiffnessand very less (negligible) deformation.

As mentioned with respect to FIGS. 2 and 3 above, in some cases thevaginal wall may be anisotropic in nature; therefore, it experiencesdifferent elongations in different directions. For example, the vaginalwall in a traverse direction is generally more elastic than in alongitudinal direction. Therefore, it may be desirable to configure themedical implant to exhibit values of the biomechanical attributesdefined to emulate the varying elongation behavior of the vaginal wallin different directions. FIG. 6B is a graphical representation of acomparison of an exemplary attribute, elongation, of the vaginal tissuein the transverse direction and the longitudinal direction. A shown, theelongation of the vaginal tissue in the transverse direction is muchlesser than the elongation in the longitudinal direction.

Referring to the graphical representations of FIGS. 6A-6B that depictthe characteristics and behavior of a vaginal tissue, the portions ofthe medical implant that are attached to vaginal tissues are configuredto behave accordingly in order to emulate the behavior of the vaginaltissues such as the anterior and posterior vaginal walls. For example,in some embodiments, the portions of the implant that attach to theanterior vaginal wall can be configured to define different stiffnesscharacteristics at different levels of loads on the implant portions.Similarly, the implant portions that attach to the posterior vaginalwall can be configured to define different characteristics in differentdirections such as the transverse direction and the longitudinaldirection and for different load values.

In some embodiments, stiffness at the low strain or deformation phasecan range from 0.431-4.15 MPa for the anterior vaginal wall in thelongitudinal direction. In some embodiments, stiffness at the highstrain or deformation phase can range from 5.15-17.28 MPa for theanterior vaginal wall in the longitudinal direction. In someembodiments, stiffness at a low strain or deformation phase can rangefrom 0.46-0.98 MPa for the posterior vaginal wall in the longitudinaldirection. In some embodiments, stiffness at a high strain ordeformation phase can range from 2.49-9.08 MPa for the posterior vaginalwall in the longitudinal direction. In some embodiments, stiffness atthe low strain or deformation phase can range from 0.385-0.415 MPa forthe anterior vaginal wall in the traverse direction. In someembodiments, stiffness at the high strain or deformation phase can rangefrom 0.370-0.61 MPa for the anterior vaginal wall in the traversedirection. In some embodiments, stiffness at the low strain ordeformation phase can range from 1.14-1.46 MPa for the posterior vaginalwall in the traverse direction. In some embodiments, stiffness at thehigh strain or deformation phase can range from 2.39-3.83 MPa for theposterior vaginal wall in the traverse direction. The values ofstiffness detailed here are a guide for vaginal tissues generally. Thevalues of stiffness can be different depending on disease state, age, orany other influencing factor. Therefore, the implant can bemade/designed accordingly to be configured for emulating thebiomechanical behavior of the vaginal tissue in accordance with thedesired characteristic behavior.

FIG. 7 is a perspective view of the medical implant 200, including thefirst flap 248 and the second flap 340 of FIG. 2 and FIG. 3respectively, placed inside a patient's body, in accordance with anembodiment of the invention. The body portions of the patient such asthe vagina V, the anterior vaginal wall AVW, the posterior vaginal wallPVW, a urethra U, and the sacrum S are illustrated in FIG. 7. FIG. 8illustrates a method 800 for placing an implant in a patient's body. Themethod 800 is described below in conjunction with FIGS. 2, 3, 4, 5, and7-9. The medical implant 200 including the first flap 248 and the secondflap 340 is used as an exemplary embodiment to illustrate and discussthe method 800. However, it must be appreciated that other implants suchas the medical implant 400 and the medical implant 500 as discussedabove can also be employed equally.

The method 800 includes inserting the first flap 248 of the medicalimplant 200 inside the body at step 802. In some embodiments, the firstflap 248 can be inserted inside the patient's body through alaparoscopic approach. In some embodiments, the method 800 includescreating an abdominal incision for delivering the medical implant insidethe body laparoscopically.

The method 800 further includes attaching the first portion 202 of themedical implant 200 at the sacrum S inside the patient's body. The firstportion 202 can be configured to define the biomechanical attributes soas to emulate the biomechanical behavior of the sacrum S in a definedset of physical conditions. The biomechanical attributes can be definedby the first set of values of respective biomechanical parametersassociated with the biomechanical attributes.

The method 800 further includes attaching the second portion 204 of thefirst flap 248 to the anterior vaginal wall AVW at step 804. Theanterior vaginal wall AVW is known to exhibit properties ofviscoelasticity, anisotropy, and viscohyperelasticity. The secondportion 204 can be configured to emulate the biomechanical behavior ofthe anterior vaginal wall AVW and define viscoelasticity, anisotropy,and viscohyperelasticity. The second portion 204 can define thebiomechanical attributes that can be defined by the second set of valuesof respective biomechanical parameters associated with the biomechanicalattributes as explained by way of FIG. 2. The first flap 248 isconfigured so that the first set of values is different from the secondset of values. The difference in values can be attributed to thedifference in the biomechanical behavior of the sacrum S and theanterior vaginal wall AVW. In some embodiments, the portion attaching tothe anterior wall is formed monolithically with the first portion 202and the transition region 206 as discussed above. It must be appreciatedthat any conventionally known or practiced methods or devices may beused for attaching the medical implant at any location inside thepatient's body.

The method 800 further includes placing the second flap 340 of themedical implant 200 over the posterior vaginal wall PVW at step 806 asdescribed below.

The first portion 302 can be configured to define the biomechanicalattributes so as to emulate the biomechanical behavior of the sacrum Sin a defined set of physical conditions. The biomechanical attributescan be defined by the first set of values of respective biomechanicalparameters associated with the biomechanical attributes. The first setof values for the first portion 202 from the first flap 248 can be sameas those for the first portion 302 from the second flap 340.

The posterior vaginal wall PVW is known to exhibit properties ofviscoelasticity, anisotropy, and viscohyperelasticity. The secondportion 304 can be configured to emulate the biomechanical behavior ofthe posterior vaginal wall PVW and define visco-elasticity, anisotropy,and viscohyperelasticity. The second portion 304 can define thebiomechanical attributes that can be defined by the third set of valuesof respective biomechanical parameters associated with the biomechanicalattributes as explained by way of FIG. 3. The second portion 304 can beconfigured to define the biomechanical attributes congruent to thebiomechanical behavior of the posterior vaginal wall. The medicalimplant 200 can be fabricated so that second flap 340 is configured tohave the third set of values corresponding to the biomechanicalattributes to be different from the second set of values correspondingto the first flap 248. Therefore, the second portion 204 of the firstflap 248 used for attaching to the anterior vaginal wall AVW defines adifferent set of values corresponding to a biomechanical parameter thanthe set of values corresponding to the same biomechanical parameter forthe second portion 302 of the second flap 340 attaching to the posteriorvaginal wall. In this way, the properties of the first flap 248 and thesecond flap 340 are different and congruent with respect to the portionsthe first flap 248 and the second flap 340 are attached to. In someembodiments, the portion attaching to the posterior vaginal wall PVW isformed monolithically with the first portion 302 and the transitionregion 306 as discussed above. It must be appreciated that anyconventionally known or practiced methods or devices may be used forattaching the medical implant at any location inside the patient's body.In some embodiments, the tow flaps can be independent from each otherand may collectively enable the medical implant 200 in emulatingbiomechanical behavior of the anterior vaginal wall AVW, posteriorvaginal wall PVW and the sacrum S inside a patient's body.

In some embodiments, the method 800 further includes cutting an unwantedportion of the medical implant 200 after placing in the body. In someembodiments, the method 800 further includes closing the abdominalincision or any other incision created for method 800.

In some embodiments, the method 800 can be used for treatment of apelvic floor disorder, in accordance with an embodiment of the presentinvention. The implant can be a dual knit mesh. The dual knit meshmaterial can be a polymer mesh, a polypropylene material, abio-absorbable material, or any other preferred material. The knitstructure defined by each of the implants 200, 400, and 500 can be anyknit structure that emulates the biomechanical properties of the vaginain the wide body region and provides stiffness in the stem region. Theimplant can be sold as a separate dual knit mesh and a standard mesh.The implant can be used for vaginal prolapse to suspend the vagina tothe sacral promontory or the sacrum after a hysterectomy termed asSacrocolpopexy or any other disorders. The implant can be placed intothe body by laparoscopic or any other means.

In some embodiments, an implant includes a first flap and a second flap.The first flap has a first portion configured to be attached proximate asacrum; a second portion configured to be attached to an anteriorvaginal wall; and a transition region lying between the first portionand the second portion. The second flap includes a portion configured tobe attached to a posterior vaginal wall. A value corresponding to abiomechanical parameter defining a biomechanical attribute of theportion of the first flap attaching to the anterior wall is differentfrom a value of the biomechanical parameter defining the biomechanicalattribute of the portion of the second flap attaching to the posteriorwall.

In some embodiments, the implant may be configured to help suspend orprovide support to a portion of the body of the patient. For example,the implant may be used to provide support to a vagina of a patient. Inother embodiments, the implant is configured to suspend or providesupport to other portions of the body, such as a portion of thegastrointestinal tract of the patient, a bladder of the patient, or arectum of the patient.

In some embodiments, an implant includes a first end portion, a secondend portion and a body in between the ends. The first end portion has abiomechanical attribute that is different in value than the samebiomechanical attribute at the second end portion.

In some embodiments, the first portion of the first flap defines a firsttype of knit structure. In some embodiments, the second portion of thefirst flap defines a second type of knit structure. In some embodiments,the first type of knit structure includes pores that are smaller incross sectional profile than the pores in the second type of knitstructure. In some embodiments, a width of the second portion issubstantially more or greater than a width of the first portion of thefirst flap. In some embodiments, the second portion includes a proximalend and a distal end, the distal end being proximate the transitionregion, wherein the width of the second portion varies from the proximalend to the distal end of the second portion. In some embodiments, thevarying second width along the second portion defines a trapezoidalshape of the second portion. In some embodiments, the transition regiondefines a third type of knit structure. In some embodiments, each of thefirst and the second flaps defines a planar shape and are configured tobe attached separately to bodily locations. In some embodiments, each ofthe value of the biomechanical parameter defining the biomechanicalattribute of the portion of the first flap attaching to the anteriorwall and the value of the biomechanical parameter defining thebiomechanical attribute of the portion of the second flap attaching tothe posterior wall is different from a value of the biomechanicalparameter of the first portion attaching proximate the sacrum.

In some embodiments, the biomechanical attribute is elasticity and thebiomechanical parameter is a modulus of elasticity. In some embodiments,the biomechanical attribute is viscoelasticity. In some embodiments, thebiomechanical attribute is viscohyperelasticity. In some embodiments,the biomechanical attribute is anisotropicity. In some embodiments, thebiomechanical attribute is resistance to creep. In some embodiments, thebiomechanical attribute is stiffness.

In some embodiments, the second flap includes a first portion defining awidth and configured to be attached proximate the sacrum; a secondportion defining a width and configured to be attached to the posteriorvaginal wall; and a transition region lying between the first portionand the second portion and monolithically joining the first portion andthe second portion.

In some embodiments, the first flap and the second flap are constructedfrom a single piece of material. In some embodiments, the first flap andthe second flap are fabricated independent of each other. In someembodiments, each of the first flap and the second flap are fabricatedfrom a linear strip of material such that the transition region of eachof the first flap and the second flap extends monolithically from eachof the first portion, and the second portion.

In some embodiments, a tubular implant includes a first portion of thetubular implant configured to be attached proximate a sacrum; atransition region extending from the first portion; a second portion ofthe tubular implant and extending from the transition regionmonolithically and including a first section and a second section andtwo slits provided laterally in the second portion configuring the firstsection as apart from the second section at a proximal end; and a lumendefined within the first and second portions of the tubular implant. Thefirst section is configured to be attached to an anterior vaginal wall,and the second section is configured to be attached to a posteriorvaginal wall.

In some embodiments, a knit structure of the first portion is differentfrom a knit structure of the second portion. In some embodiments, a knitstructure of the first section is different from a knit structure of thesecond section of the section portion. In some embodiments, a valuecorresponding to a biomechanical parameter defining a biomechanicalattribute of the first section wall is different from a value of thebiomechanical parameter of the second section.

In some embodiments, a method for placing an implant in a body of apatient, the method includes inserting the implant inside the body;attaching a portion of the implant to an anterior vaginal wall, whereinthe portion attaching to the anterior vaginal wall defines a first valueof a biomechanical parameter defining a biomechanical attribute;attaching a portion of the implant to a posterior vaginal wall, whereinthe portion attaching to the posterior vaginal wall defines a secondvalue of the biomechanical parameter such that the second valuecorresponding to the portion attaching to the posterior wall isdifferent from the first value corresponding to the portion attaching tothe anterior wall.

In some embodiments, the method includes creating an abdominal incisionfor delivering the implant inside the body laparoscopically. In someembodiments, the portions attaching to the anterior wall, and theposterior wall define regions of a tubular structure of the implant. Insome embodiments, the tubular structure includes a portion configured tobe attached proximate a sacrum, the method further comprising attachingthe portion proximate the sacrum.

In some embodiments, the portion attaching to the anterior wall isformed monolithically with a second portion configured to be attachedproximate a sacrum and a transition region between the portion attachingto the anterior wall and the second portion attaching proximate thesacrum, the method further comprising attaching the second portionproximate the sacrum. In some embodiments, the portion attaching to theposterior wall is formed monolithically with a second portion configuredto be attached proximate a sacrum and a transition region between theportion attaching to the posterior wall and the second portion attachingproximate the sacrum, the method further comprising attaching the secondportion proximate the sacrum.

In some embodiments, the method includes cutting an unwanted portion ofthe implant after placing in the body. In some embodiments, the methodincludes closing the abdominal incision and other incisions.

While the invention has been disclosed in connection with the preferredembodiments shown and described in detail, various modifications andimprovements thereon will become readily apparent to those skilled inthe art. Accordingly, the spirit and scope of the present invention isnot to be limited by the foregoing examples, but it is to be understoodin the broadest sense allowable by law.

What is claimed is:
 1. An implant comprising: a first flap formed of afirst sheet of material including: a first portion configured to beattached proximate a sacrum, the first portion defining a plurality offirst pores having a first size, the first portion having a first knitpattern; a second portion configured to be attached to an anteriorvaginal wall, the second portion defining a plurality of second poreshaving a second size, the second size being greater than the first size,the second portion having a second knit pattern different than the firstknit pattern; and a transition region disposed between the first portionand the second portion, wherein a value corresponding to a biomechanicalparameter defining a biomechanical attribute of the second portion alonga first direction is different from a value of the biomechanicalparameter defining the biomechanical attribute of the first portionalong a second direction, the second direction being in a longitudinaldirection, the first direction being transverse with respect to thelongitudinal direction, the transition region having a third knitpattern different than the first knit pattern and different than thesecond knit pattern, at least one end portion of the transition regionextends from one end portion of the first portion or one end portion ofthe second portion; and a second flap formed of a second sheet ofmaterial, the second sheet of material being separate from the firstsheet of material, the second flap including: a first portion configuredto be attached proximate the sacrum; a second portion configured to beattached to a posterior vaginal wall; and a transition region disposedbetween the first portion and the second portion.
 2. The implant ofclaim 1, wherein the second portion of the second flap defines aplurality of third pores having a third size.
 3. The implant of claim 1,wherein a width of the second portion of the first flap is larger than awidth of the first portion of the first flap, and a width of the secondportion of the second flap is larger than a width of the first portionof the second flap.
 4. The implant of claim 3, wherein the secondportion of the first flap includes a proximal end and a distal end, thedistal end being proximate the transition region of the first flap,wherein the width of the second portion of the first flap varies fromthe proximal end to the distal end of the second portion of the firstflap.
 5. The implant of claim 4, wherein the varying width of the secondportion of the first flap defines a trapezoidal shape of the secondportion of the first flap.
 6. The implant of claim 1, wherein the firstsheet of material is mesh, and the second sheet of material is mesh. 7.The implant of claim 1, wherein the first portion of the first flap iscoupled to the second portion of the first flap at the transition regionof the first flap with one or more sutures, and the first portion of thesecond flap is coupled to the second portion of the second flap at thetransition region of the second flap with one or more sutures.
 8. Theimplant of claim 1, wherein the biomechanical attribute is elasticityand the biomechanical parameter is a modulus of elasticity.
 9. Theimplant of claim 1, wherein the biomechanical attribute isviscoelasticity or viscohyperlasticity.
 10. The implant of claim 1,wherein the first portion of the first flap defines a set ofbiomechanical attributes that emulate a biomechanical behavior of thesacrum, the second portion of the first flap defines a set ofbiomechanical attributes that emulate a biomechanical behavior of theanterior vaginal wall, the first portion of the second flap defines aset of biomechanical attributes that emulate the biomechanical behaviorof the sacrum, and the second portion of the second flap defines a setof biomechanical attributes that emulate a biomechanical behavior of theposterior vaginal wall.
 11. The implant of claim 1, wherein thebiomechanical attribute is anisotropicity.
 12. The implant of claim 1,wherein the biomechanical attribute is resistance to creep.
 13. Theimplant of claim 1, wherein the biomechanical attribute is stiffness.14. The implant of claim 1, wherein the first sheet of material has aweight less than 30 grams per square meter.
 15. An implant, comprising:a first sheet of mesh material having a first portion, a second portion,and a transition region disposed between the first portion and thesecond portion, the first portion configured to be attached proximate asacrum, the second portion configured to be attached to an anteriorvaginal wall, wherein a value corresponding to a biomechanical parameterof the first portion of the first sheet of material is different from avalue of the biomechanical parameter of the second portion of the firstsheet of material, the first portion of the first sheet of materialhaving a weight that is different than the second portion of the firstsheet of material, the first portion of the first sheet of materialdefining a plurality of first pores having a first size, the secondportion of the first sheet of material defining a plurality of secondpores having a second size, the second size being greater than the firstsize, wherein the biomechanical parameter is stiffness, and the value ofthe biomechanical parameter of the second portion of the first sheet ofmaterial is within a range of 5.515-17.28 MPa in a first direction; anda second sheet of mesh material, the second sheet of mesh material beingseparate from the first sheet of mesh material, the second sheet of meshmaterial having a first portion and a second portion, the first portionof the second sheet of mesh material configured to be attached proximateto the sacrum, the second portion of the second sheet of mesh materialconfigured to be attached to a posterior vaginal wall; wherein the firstportion of the first sheet of material has a first type of knit pattern,the second portion of the first sheet of material has a second type ofknit pattern, the transition region of the first sheet of material has athird type of knit pattern, and the second portion of the second sheetof material has a fourth type of knit pattern, wherein the first type ofknit pattern, the second type of knit pattern, the third type of knitpattern, and the fourth type of knit pattern are different from eachother.
 16. The implant of claim 15, wherein the value of thebiomechanical parameter of the second portion of the first sheet ofmaterial is within a range of 0.385-0.415 MPa in a second direction, thesecond direction being perpendicular to the first direction.
 17. Theimplant of claim 15, wherein a value corresponding to a biomechanicalparameter of stiffness of the first portion of the second sheet ofmaterial is different from a value of the biomechanical parameter ofstiffness of the second portion of the second sheet of material.
 18. Theimplant of claim 15, wherein one portion of the first sheet of materialhas a weight greater than 30 grams per square meter and another portionof the first sheet of material has a weight of less than 30 grams persquare meter.
 19. An implant comprising: a first flap formed of a firstsheet of material including: a first portion configured to be attachedproximate a sacrum, the first portion defining a plurality of firstpores having a first size, the first portion having a first knitpattern, the first portion defines a first length along a first sideextending from a proximal end portion to the distal end portion, and asecond length along a second side extending from the proximal endportion to the distal portion, the first length being different than thesecond length; a second portion configured to be attached to an anteriorvaginal wall, the second portion defining a plurality of second poreshaving a second size, the second size being greater than the first size,the second portion having a second knit pattern different than the firstknit pattern; and a transition region disposed between the first portionand the second portion, wherein a value corresponding to a biomechanicalparameter defining a biomechanical attribute of the second portion alonga first direction is different from a value of the biomechanicalparameter defining the biomechanical attribute of the first portionalong a second direction, the second direction being in a longitudinaldirection, the first direction being transverse with respect to thelongitudinal direction, the transition region having a third knitpattern different than the first knit pattern and different than thesecond knit pattern; and a second flap formed of a second sheet ofmaterial, the second sheet of material being separate from the firstsheet of material, the second flap including: a first portion configuredto be attached proximate the sacrum; a second portion configured to beattached to a posterior vaginal wall; and a transition region disposedbetween the first portion and the second portion.